2024 Outlook For AI In Trials, Tips For Implementing ICH E6(R3) In A Risk Averse Culture, and More
Clinical Leader
A resource and forum to investigate and resolve the common struggles related to running effective clinical trials.
Welcome to the Clinical Trial Insights newsletter, featuring strategic insights and expert opinions on designing and running clinical trials. Each edition covers the latest trending articles on ClinicalLeader.com.
In this week's issue, we'll explore what experts think will happen with AI in 2024, tips for reducing your organization's anxiety while implementing ICH E6(R3), why it's important to understand your TMF customers, opportunities for AI to assist cell & gene therapy companies, and other popular insights.
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TOP 5 READS OF THE PAST WEEK
When Clinical Leader executive editor Abby Proch asked experts across the continuum about their thoughts for the new year, she got a little bit of everything. In part one of this preview of clinical trials trends for 2024, experts discuss the applications of AI in clinical research.
Moving away from the ideal of perfect data to delivering fit for purpose data opens the door to ambiguity and can lead to anxiety that something crucial will be missed. Christina Dinger shares several pointers on how to facilitate a transition to an agile, multi-faceted, and continuous risk and issue management approach aligned with the Statistical Analysis Plan.
Could your director of clinical operations or TMF manager identify all customers of the TMF? Perhaps not. Meeting the needs of regulators is critical. Inspection-readiness is an essential objective in TMF planning. Ken Keefer explains why knowing all customers is so important to efficient, high-quality trials.
Lowering barriers to participation could boost the diversity and inclusion of patients in clinical trials. Review this gender, race, and ethnicity data provided by PCM TRIALS - Quality Mobile Research to understand the differences that mobile visits from a certified mobile research nurse can make.
领英推荐
Although AI/ML is still in a nascent stage in the cell and gene therapy sector, it has an enormous amount of potential to transform overall business models, early R&D, clinical trials, manufacturing and operations, and regulatory compliance support in these key ways identified by PA Consulting's Yoshio Hagiwara, PhD, Paolo Siciliano, and Willem van Asperen.
MORE TO EXPLORE
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